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E5SU711

Millipore

NovaSeptum® GO Preloaded System with High Purity Bag, 5-port

sterile; β-irradiated

Synonym(s):
NovaSeptum® GO High Purity Bag

material

316 stainless steel cannula (ASTM®)
PureFlex polyethylene bag
TPE tubing
polyester body (platinum-cured)
silicone septum (platinum-cured)

Quality Level

Agency

according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 88 Biological Reactivity (all component materials)

sterility

sterile; β-irradiated

product line

NovaSeptum® GO

feature

autoclavable: no

parameter

-80-50 °C temp. range (-112-122 °F)
0.50 bar max. pressure (7.25 psi) (for 1000 mL)
0.50 bar max. pressure (7.25 psi) (up to 250 mL)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

female Luer-Lok® outlet (3-piece with injection site)
male Luer-Lok® outlet (3-piece )

application(s)

cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
sterile sampling
viral therapy

storage temp.

room temp

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This Item
E9SU711E5SU221E9SU221
material

316 stainless steel cannula (ASTM®), PureFlex polyethylene bag, TPE tubing, polyester body (platinum-cured), silicone septum (platinum-cured)

material

316 stainless steel cannula, PureFlex polyethylene bag (fluid contact layer), TPE tubing, polyester body, silicone septum (platinum-cured)

material

316 stainless steel cannula, polypropylene bag, silicone septum (platinum-cured), silicone tubing

material

316 stainless steel cannula, polyester body, polyethylene bottle (fluid contact layer), silicone septum (platinum-cured ), silicone tubing

agency

according to ISO 11137 (sterilization)

agency

according to ISO 11137 (sterilization), meets ISO 146441
146441, meets ISO 88 biological reactivity (all component materials)

agency

according to ISO 11137 (sterilization), according to ISO 146441, meets USP 88 Biological Reactivity (all component materials)

agency

according to ISO 11137 (sterilization), certified by the ISO 146441, meets USP 88 biological reactivity (all component materials)

sterility

sterile; β-irradiated

sterility

sterile; β-irradiated

sterility

sterile; β-irradiated

sterility

sterile; β-irradiated

product line

NovaSeptum® GO

product line

NovaSeptum® GO

product line

NovaSeptum® GO

product line

NovaSeptum® GO

feature

autoclavable: no

feature

autoclavable: no

feature

autoclavable

feature

autoclavable

parameter

-80-50 °C temp. range (-112-122 °F)

parameter

-20-50 °C temp. range (-4-122 °F) (for 1000 mL), -80-50 °C temp. range (-112-122 °F) (for 50 mL to 250 mL), 0.30 bar max. pressure (4.35 psi) at ±25 °C (for 1000 mL), 0.50 bar max. pressure (7.25 psi) at ±25 °C (for up to 250 mL)

parameter

-20-125 °C temp. range (-4-257 °F), 0.30 bar max. pressure (4.35 psi)

parameter

-20-125 °C temp. range (-4-257 °F), 0.30 bar max. pressure (4.35 psi) at ±25 °C

General description

Device configuration: single unit sampling - preloaded system
TheNovaSeptum® GO pre-loaded disposable magazine is available with various standard configurations using NovaSeptum® GO high purity bags, autoclavable bags, bottles, transfer tubes or accurate volume (AV) syringe units. Other configurations are available upon request. For an optimal aseptic solution, use the NovaSeptum® GO pre-loaded disposable magazine together with a 1.5" or 2" NovAseptic® connector and NovaSeptum® GO pre-loaded starter kit (5/9 shot stainless steel base). Ideal for sampling from aseptic and sterile processes, the NovaSeptum® GO sterile sampling system provides consistently representative samples, safely and securely.

Application

sterile sampling

Packaging

E5SU711-10050 (5x50 ml bags, 8 units per box)
E5SU711-10100 (5x100 ml bags, 8 units per box)
E5SU711-10250 (5x250 ml bags, 7 units per box)
E5SU711-11000 (5x1000 ml bags, 6 units per box)

Components

  • Septum: Platinum-cured silicone
  • Body: Polyester
  • Cannula: ASTM® 316 L Stainless steel
  • Fluid contact layer (bag): Polyethylene film (PureFlex film)
  • Tubing: Thermoplastic elastomer (TPE)
  • Outlet Tubing: 3-piece Luer-Lok®, containing a male, female and an injection site


Preparation Note

Units are integrity tested at regular intervals during manufacturing.
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTIC is a registered trademark of Millipore AB - Sweden
NOVASEPTUM is a registered trademark of Millipore AB - Sweden
PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany

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